Trac Services | Regulatory Health Check service - avoid non-compliance
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Regulatory Health Check

25 th Sep Regulatory Health Check

 

Regulatory Health Check


As CMC experts, we at TRAC come across all manner of Module 3 regulatory compliance issues.  These are often caused by a small human error which have then ‘snow balled’ due to the time taken to identify and correct the mistake.

Although sometimes ‘stumbled upon’ during routine work, detecting compliance issues may not be possible without an in-depth gap analysis or review. This can be time consuming and costly and hence it is far preferable to prevent them occurring in the first place. This saves time, expense and your company’s reputation with the regulatory authority.

Common causes of regulatory compliance issues are listed below with possible solutions of how to avoid these going forward.


Regular Compliance Issues:

Issue:

Changes at manufacturing/ testing sites have been implemented without regulatory assessment.

Solutions:

Ensure a robust change control process is in place at the manufacturing site and all employees are aware and trained in their responsibilities. Make them aware that even minor, seemingly unimportant changes may have regulatory impact. The best person to assess this impact is an experienced regulatory professional.

Issue:

Additional changes are added into a project at a late stage. This can mean that the changes have not had time to be correctly assessed for impact. It can also mean that they are introduced after the initial wave of despatches resulting in a discrepancy globally in the registered detail if the event is not sufficiently recorded.

Solutions:

Ensure that the project plan and change control is updated to capture the change in scope. If it is too late to include the change in all markets then raise a new change control to ensure that these markets are not missed. Knowledge documents/ core reference files are a good way to capture the history of a product. Update accordingly so that people who work on the project or product in future understand the reason for these discrepancies and the action that needs to be taken.

Issue:

Dossiers despatched to affiliates have not been submitted.

Solutions:

Ensure good regulatory tracking systems or processes are in place to capture the status of all regulatory submissions. Ensure all staff are adequately trained in their responsibilities to accurately update these systems. Regularly follow up on the status of all despatches/ submissions until an approval is received for each market.

Issue:

Implementable changes (e.g. Type 1A, Annual reportables) have been implemented but then it is forgotten to update dossier and submit changes within 12 months.

Solutions:

Keep a central document which lists all changes and their implementation dates. Enter the variations into the aforementioned regulatory tracking systems with a planned dispatch date within the required 12 months deadline. This will keep the variations required visible.

Issue:

Market specific changes, e.g. due to Response to Questions (RTQs) or commitments, are not correctly logged and future submissions default to the global registered details.

Solutions:

The history of the response/ commitment including original questions, subsequent communications and the resulting response dossier should be captured in the appropriate document repository system and regulatory tracking system. As mentioned previously Knowledge documents/ core reference files are a good way to capture the history of a product and any market specific differences that are registered. Efficient use of naming conventions in the regulatory authoring systems (e.g. documentum) can help regulatory executives select the correct component during the authoring stage.

Issue:

Not all the components affected by a change are updated and included in a submission package e.g. P1 and P2 updates in a variation to the P7. This leads to inconsistency across registered detail.

Solutions:

Such inconsistencies can be avoided by a robust authoring and review process. A peer review and final approval step by experienced regulatory professionals can spot any deficiencies in the dossier for submission.

Issue:

Excessive detail registered meaning that minor change which usually has no regulatory compliance causes out of compliance issue.

Solutions:

The registering of excessive details such as suppliers’ names, suppliers’ designations for packaging materials or specific makes and models of manufacturing equipment should be avoided. Using generic but accurate descriptions in regulatory dossiers means that the manufacturing site can switch to an equivalent without the need for a regulatory submission. It must be noted that the change control process should still be followed and a regulatory assessment undertaken to ensure compliance.

Issue:

Errors or inaccuracies during authoring of technical components.

Solutions:

In addition to a two-stage regulatory review process, as described previously, a thorough technical review should be undertaken by a subject expert. This can help identify any technical errors, misunderstandings or knowledge gaps that have been transferred into the regulatory dossier. These errors can also be reduced by incorporating into the change control process documentation, generated by the subject expert, that clearly illustrates the proposed technical variations.

Issue:

Dossiers being adapted locally prior to submission and the changes not being sufficiently communicated or captured. This may be due to dossiers being despatched which contain information that cannot be registered in a local market. E.g. multiple manufacturers included in 3.2.P.3.1 when a market is single source.

Solutions:

This is avoided firstly by good regulatory intelligence for all the markets that you intend to dispatch to and also good communication with the local affiliates with whom you are working.  It is also highly recommended that SOPs state that no alterations are made by the local affiliate other than those required for translations. If edits are required then the affiliate should feed these back for central regulatory to complete. As described previously for market specific components resulting from questions from an authority, any market specific differences need to be adequately captured. For example, it may be allowable in a market to register a second manufacturing site on a separate license and hence a second dossier. Would it be clear to a regulatory executive in future that both sites are still registered for manufacture if they were to find the later dossier? Correctly updating regulatory tracking systems and Knowledge documents can capture this history and avoid confusion in the future.

Issue:

Regulatory standards/ Requirements have moved on and the dossiers are not in-line with modern standards.

Solutions:

Manufacturing sites and regulatory departments should keep abreast of the recent intelligence updates. Whilst it may not seem like an immediate issue to update the specifications for a well-established product, this may be queried on the submission of a routine variation or registration of the product in a new market. Hence, for example, putting off development studies for new methods or tests for an update to specification may prove a false economy if this delays the approval of other variations or launches.


As can be seen the solution to nearly all of these issues is to have the correct systems and processes in place with all staff adequately trained and adhering to them. A corner cut to save time on one project can soon snow ball into a significant remediation project all of its own. If you have concerns regarding the compliance state of your regulatory dossiers, TRAC would be happy to help. Get in touch to discuss any gap analysis requirements that you may have.

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